SmokingPhase 3STEPNCT01065506

Smoking Termination Enhancement Project (STEP)

A Phase 3 study testing Cognitive Behavioral Treatment, Nicotine Patch and Wellness Program in people with Smoking, run by Southern Methodist University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: Cognitive Behavioral Treatment, Nicotine Patch and Wellness Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteUnited States
Study dates: Sep 2009to Aug 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged between 18 and 65 years old
Capable of providing informed consent, attend all study visits and comply with the protocol
Daily smoker for at least one year and currently smoke an average of at least 10 cigarettes per day
Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
Score of 20 or greater on 16-item Anxiety Sensitivity Index
Physically inactive as defined as participating in moderate-intensity exercise less than 2 days/week (duration must be 30 minutes or less each time)

Who cannot join

Use of other tobacco products
General medical condition(s) that contraindicate exercise
Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving treatment for high blood pressure
Blood lipid levels ≥ 240 mg/dl with LDL-C ≥ 160 mg/dl or triglyceride levels ≥ 300 mg/dl (individuals receiving medical treatment for lipid abnormalities with lipid levels above the cut-offs will be eligible with physician written approval)
Body mass index ≥40
Currently suicidal or high suicide risk

Show all 11Show fewer

Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
Currently pregnant, planning on becoming pregnant in the next year, or current breastfeeding
Alcohol or drug dependence; abuse of depressants, dissociative anesthetics, hallucinogens, opioids, or cocaine within the last 6 months
Psychotherapy initiated within the past three months, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or mood disorder other than general supportive therapy
Current use of any psychotherapy or pharmacotherapy for smoking cessation not provided by the researchers, including Chantix, Zyban, Welbutrin and Nortriptyline.

Trial locations and contacts

1 site in 1 country.

United States1 site

Southern Methodist University
Dallas, Texas, 75206

Other trials in United States

About this study

The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercise) help increase the effectiveness of current standard programs for smoking cessation.

Conditions: Smoking
Being tested: Cognitive Behavioral Treatment, Nicotine Patch, Wellness Program, Aerobic Exercise
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Behavioral TreatmentBehavioural
Cognitive Behavioral Treatment
Nicotine PatchDrug
Nicotine Patch
Wellness ProgramBehavioural
Wellness Program
Aerobic ExerciseBehavioural
Aerobic Exercise

Study groups in NCT01065506
Study group	Role	What they receive
Standard Care plus Wellness Program	Active comparator	Not described Receives: Behavioral: Cognitive Behavioral Treatment; Drug: Nicotine Patch; Behavioral: Wellness Program
Standard Care plus Exercise Program	Active comparator	Not described Receives: Behavioral: Cognitive Behavioral Treatment; Drug: Nicotine Patch; Behavioral: Aerobic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day
Point Prevalence Abstinence (PPA) was defined as not smoking [even a single puff] at the end of treatment and/or on the day of follow-up
Measured: End of treatment (10 weeks post quit day) and 30-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Aug 2013

First posted9 Feb 2010 (estimated)
Study startSep 2009
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01065506
Sponsor's protocol ID: R01DA027533
Other IDs: 1R01DA027533-01
Acronym: STEP
Status last verified: Jan 2016
First submitted: 8 Feb 2010
Last updated: 4 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Tart CD, Leyro TM, Richter A, Zvolensky MJ, Rosenfield D, Smits JA. Negative affect as a mediator of the relationship between vigorous-intensity exercise and smoking. Addict Behav. 2010 Jun;35(6):580-5. doi: 10.1016/j.addbeh.2010.01.009. Epub 2010 Feb 1.
PubMed 20171786
Smits JA, Rosenfield D, Mather AA, Tart CD, Henriksen C, Sareen J. Psychotropic medication use mediates the relationship between mood and anxiety disorders and obesity: findings from a nationally representative sample. J Psychiatr Res. 2010 Nov;44(15):1010-6. doi: 10.1016/j.jpsychires.2010.04.007.
PubMed 20434171
Medina JL, Vujanovic AA, Smits JA, Irons JG, Zvolensky MJ, Bonn-Miller MO. Exercise and coping-oriented alcohol use among a trauma-exposed sample. Addict Behav. 2011 Mar;36(3):274-7. doi: 10.1016/j.addbeh.2010.11.008. Epub 2010 Nov 10.
PubMed 21111538
Smits JA, Bonn-Miller MO, Tart CD, Irons JG, Zvolensky MJ. Anxiety sensitivity as a mediator of the relationship between moderate-intensity exercise and coping-oriented marijuana use motives. Am J Addict. 2011 Mar-Apr;20(2):113-9. doi: 10.1111/j.1521-0391.2010.00115.x. Epub 2011 Feb 1.
PubMed 21314753
Smits JA, Tart CD, Rosenfield D, Zvolensky MJ. The interplay between physical activity and anxiety sensitivity in fearful responding to carbon dioxide challenge. Psychosom Med. 2011 Jul-Aug;73(6):498-503. doi: 10.1097/PSY.0b013e3182223b28. Epub 2011 Jun 23.
PubMed 21700713
Mathew AR, Norton PJ, Zvolensky MJ, Buckner JD, Smits JA. Smoking Behavior and Alcohol Consumption in Individuals With Panic Attacks. J Cogn Psychother. 2011 Feb 1;25(1):61-70. doi: 10.1891/0889-8391.25.1.61.
PubMed 21915160
Zvolensky MJ, Buckner JD, Norton PJ, Smits JA. Anxiety, Substance Use, and Their Co-Occurrence: Advances in Clinical Science. J Cogn Psychother. 2011;25(1):3-6. doi: 10.1891/0889-8391.25.1.3.
PubMed 21857769
Deboer LB, Tart CD, Presnell KE, Powers MB, Baldwin AS, Smits JA. Physical activity as a moderator of the association between anxiety sensitivity and binge eating. Eat Behav. 2012 Aug;13(3):194-201. doi: 10.1016/j.eatbeh.2012.01.009. Epub 2012 Jan 28.
PubMed 22664396
Smits JA, Zvolensky MJ, Davis ML, Rosenfield D, Marcus BH, Church TS, Powers MB, Frierson GM, Otto MW, Hopkins LB, Brown RA, Baird SO. The Efficacy of Vigorous-Intensity Exercise as an Aid to Smoking Cessation in Adults With High Anxiety Sensitivity: A Randomized Controlled Trial. Psychosom Med. 2016 Apr;78(3):354-64. doi: 10.1097/PSY.0000000000000264.
PubMed 26513517
Smits JA, Zvolensky MJ, Rosenfield D, Marcus BH, Church TS, Frierson GM, Powers MB, Otto MW, Davis ML, DeBoer LB, Briceno NF. The efficacy of vigorous-intensity exercise as an aid to smoking cessation in adults with elevated anxiety sensitivity: study protocol for a randomized controlled trial. Trials. 2012 Nov 13;13:207. doi: 10.1186/1745-6215-13-207.
PubMed 23148822

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Smoking Termination Enhancement Project (STEP)
ClinicalTrials.gov ID: NCT01065506
Acronym / sponsor ID: STEP / R01DA027533
Conditions: Smoking
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Southern Methodist UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Sep 2009
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 9 Feb 2010 (estimated)
Results: Posted 4 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard Care plus Wellness Program	Active comparator	Behavioral: Cognitive Behavioral Treatment, Drug: Nicotine Patch, Behavioral: Wellness Program
Standard Care plus Exercise Program	Active comparator	Behavioral: Cognitive Behavioral Treatment, Drug: Nicotine Patch, Behavioral: Aerobic Exercise

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Aged between 18 and 65 years old
Capable of providing informed consent, attend all study visits and comply with the protocol
Daily smoker for at least one year and currently smoke an average of at least 10 cigarettes per day
Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
Score of 20 or greater on 16-item Anxiety Sensitivity Index

Key exclusion criteria (11 listed)

Use of other tobacco products
General medical condition(s) that contraindicate exercise
Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving treatment for high blood pressure
Blood lipid levels ≥ 240 mg/dl with LDL-C ≥ 160 mg/dl or triglyceride levels ≥ 300 mg/dl (individuals receiving medical treatment for lipid abnormalities with lipid levels above the cut-offs will be eligible with physician written approval)
Body mass index ≥40

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Behavioral TreatmentCognitive Behavioral Treatment	Behavioural	Standard Care plus Exercise Program, Standard Care plus Wellness Program
Nicotine PatchNicotine Patch	Drug	Standard Care plus Exercise Program, Standard Care plus Wellness Program
Wellness ProgramWellness Program	Behavioural	Standard Care plus Wellness Program
Aerobic ExerciseAerobic Exercise	Behavioural	Standard Care plus Exercise Program

Primary outcome

Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day
Time frame: End of treatment (10 weeks post quit day) and 30-week follow-up
Point Prevalence Abstinence (PPA) was defined as not smoking [even a single puff] at the end of treatment and/or on the day of follow-up

Results and safety

Results posted to the registry on 4 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Care Plus Wellness Program	64	32
Standard Care Plus Exercise Program	72	34

Primary outcome: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day

Time frame: End of treatment (10 weeks post quit day) and 30-week follow-up. Number. Unit: number of participants

Measure	Standard Care Plus Wellness Program n = 44	Standard Care Plus Exercise Program n = 37
End of treatment	5	9
Follow-up (n=35, 34)	4	9

Population analysed: Participants who completed the end of treatment assessment

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Care Plus Wellness Program	1 of 64 (1.6%)	0 of 64 (0%)	Not reported
Standard Care Plus Exercise Program	1 of 72 (1.4%)	0 of 72 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20171786Tart CD, Leyro TM, Richter A, Zvolensky MJ, Rosenfield D, Smits JA. Negative affect as a mediator of the relationship between vigorous-intensity exercise and smoking. Addict Behav. 2010 Jun;35(6):580-5. doi: 10.1016/j.addbeh.2010.01.009. Epub 2010 Feb 1.
Background: PubMed 20434171Smits JA, Rosenfield D, Mather AA, Tart CD, Henriksen C, Sareen J. Psychotropic medication use mediates the relationship between mood and anxiety disorders and obesity: findings from a nationally representative sample. J Psychiatr Res. 2010 Nov;44(15):1010-6. doi: 10.1016/j.jpsychires.2010.04.007.
Background: PubMed 21111538Medina JL, Vujanovic AA, Smits JA, Irons JG, Zvolensky MJ, Bonn-Miller MO. Exercise and coping-oriented alcohol use among a trauma-exposed sample. Addict Behav. 2011 Mar;36(3):274-7. doi: 10.1016/j.addbeh.2010.11.008. Epub 2010 Nov 10.
Background: PubMed 21314753Smits JA, Bonn-Miller MO, Tart CD, Irons JG, Zvolensky MJ. Anxiety sensitivity as a mediator of the relationship between moderate-intensity exercise and coping-oriented marijuana use motives. Am J Addict. 2011 Mar-Apr;20(2):113-9. doi: 10.1111/j.1521-0391.2010.00115.x. Epub 2011 Feb 1.
Background: PubMed 21700713Smits JA, Tart CD, Rosenfield D, Zvolensky MJ. The interplay between physical activity and anxiety sensitivity in fearful responding to carbon dioxide challenge. Psychosom Med. 2011 Jul-Aug;73(6):498-503. doi: 10.1097/PSY.0b013e3182223b28. Epub 2011 Jun 23.
Background: PubMed 21915160Mathew AR, Norton PJ, Zvolensky MJ, Buckner JD, Smits JA. Smoking Behavior and Alcohol Consumption in Individuals With Panic Attacks. J Cogn Psychother. 2011 Feb 1;25(1):61-70. doi: 10.1891/0889-8391.25.1.61.
Background: PubMed 21857769Zvolensky MJ, Buckner JD, Norton PJ, Smits JA. Anxiety, Substance Use, and Their Co-Occurrence: Advances in Clinical Science. J Cogn Psychother. 2011;25(1):3-6. doi: 10.1891/0889-8391.25.1.3.
Background: PubMed 22664396Deboer LB, Tart CD, Presnell KE, Powers MB, Baldwin AS, Smits JA. Physical activity as a moderator of the association between anxiety sensitivity and binge eating. Eat Behav. 2012 Aug;13(3):194-201. doi: 10.1016/j.eatbeh.2012.01.009. Epub 2012 Jan 28.
Derived from this study: PubMed 26513517Smits JA, Zvolensky MJ, Davis ML, Rosenfield D, Marcus BH, Church TS, Powers MB, Frierson GM, Otto MW, Hopkins LB, Brown RA, Baird SO. The Efficacy of Vigorous-Intensity Exercise as an Aid to Smoking Cessation in Adults With High Anxiety Sensitivity: A Randomized Controlled Trial. Psychosom Med. 2016 Apr;78(3):354-64. doi: 10.1097/PSY.0000000000000264.
Derived from this study: PubMed 23148822Smits JA, Zvolensky MJ, Rosenfield D, Marcus BH, Church TS, Frierson GM, Powers MB, Otto MW, Davis ML, DeBoer LB, Briceno NF. The efficacy of vigorous-intensity exercise as an aid to smoking cessation in adults with elevated anxiety sensitivity: study protocol for a randomized controlled trial. Trials. 2012 Nov 13;13:207. doi: 10.1186/1745-6215-13-207.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jasper Smits, PhD principal investigator

Southern Methodist University

Michael Zvolensky, PhD principal investigator

University of Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cognitive Behavioral Treatment, Nicotine Patch and Wellness Program in people with Smoking, run by Southern Methodist University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (time frame: End of treatment (10 weeks post quit day) and 30-week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01065506, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.